Open Label, Fixed Sequences, One-way Cross-over Study to Determine the Effects of Multiple Doses BAY1817080 (150 mg) on the Pharmacokinetics of a 5 mg Dose Rosuvastatin in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve of rosuvastatin without concomitant administration of BAY1817080 (AUC)
研究概览
简要总结
Researchers in this study want to learn how the study drug BAY1817080 interacts with another drug called rosuvastatin (brand name: Crestor) and affects the way the body absorbs, distributes and excretes rosuvastatin in healthy adult male and female participants (drug-drug interaction study). The study drug BAY1817080 is a new drug under development with a goal to suppress pain and chronic cough. It works by binding to and blocking proteins related to pain in the body. Rosuvastatin is an approved and marketed drug to lower high levels of "bad" cholesterol (a waxy, fat-like substance found in blood). Both drugs interact with the same proteins (molecules) in the human body, and as a result, the study drug may affect the way rosuvastatin is taken up and used by the body when applied together.
Participants in this study will be asked to visit the clinic 3 times over a period of 3 to 4 weeks. Each participant will receive rosuvastatin tablets twice with at least 11 days in between and the study drug tablets twice daily for 14 days. Blood samples will be taken from the participants to measure the blood levels of rosuvastatin.
详细描述
The primary objective of the study is to investigate the influence of multiple doses of BAY1817080 on the pharmacokinetics of rosuvastatin given concomitantly. Secondary objective is to investigate the safety of BAY1817080.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is healthy as determined by the investigator
- •White or Black race
- •Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m² at screening
- •Body weight of at least 50 kg at screening
排除标准
- •Known or suspected allergy or hypersensitivity to BAY1817080, rosuvastatin or any of their excipients
- •Asian race
- •Contraindications to rosuvastatin
- •Any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, within 1 week prior to the first study intervention administration or during the study until follow-up (occasional use of ibuprofen is permissible)
- •History of or positive COVID-19 test or contact with COVID-19 positive subject in past 4 weeks
研究组 & 干预措施
Healthy subjects_Period 1
Healthy adults from USA receive a single dose of rosuvastatin (interaction drug) in Period 1.
干预措施: Rosuvastatin (Drug)
Healthy subjects_Period 2
The healthy adults from Period 1 receive both rosuvastatin + BAY1817080 in Period 2.
干预措施: Rosuvastatin + BAY1817080 (Drug)
结局指标
主要结局
Area under the concentration-time curve of rosuvastatin without concomitant administration of BAY1817080 (AUC)
时间窗: Predose and up to 15 hours after drug on Day 1, 0 and 12 hours on Day 2, 0 hours on Day 3, 4 and 5 of Period 1
Maximum plasma concentration of rosuvastatin without concomitant administration of BAY1817080 (Cmax)
时间窗: Predose and up to 15 hours after drug on Day 1, 0 and 12 hours on Day 2, 0 hours on Day 3, 4 and 5 of Period 1
Maximum plasma concentration of rosuvastatin after concomitant administration of BAY1817080 (Cmax1)
时间窗: Predose and up to 15 hours after rosuvastatin on Day 8, 0 and 12 hours on Day 9, 0 hour on Days 10, 11, 12, 13, 14 and 15 of Period 2
Area under the concentration-time curve of rosuvastatin after concomitant administration of BAY1817080 (AUC1)
时间窗: Predose and up to 15 hours after rosuvastatin on Day 8, 0 and 12 hours on Day 9, 0 hour on Days 10, 11, 12, 13, 14 and 15 of Period 2
次要结局
- Number of participants with treatment-emergent adverse events (TEAEs)(Up to 10 weeks)
- Severity of treatment-emergent adverse events(Up to 10 weeks)